Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Teva Pharmaceutical Industries |
---|---|
Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00326625 |
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).
Condition | Intervention | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis |
Drug: Parenteral Drug / 40 mg Glatiramer Acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
Enrollment: | 300 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Teva Benelux | |
Haarlem, Belgium | |
France | |
Teva France | |
Paris, France | |
Germany | |
Teva Germany | |
Moerfelden-Walldorf, Germany | |
Israel | |
Teva Israel | |
Tel Aviv, Israel | |
Italy | |
Teva Italy | |
Milano, Italy | |
United Kingdom | |
Teva UK | |
Aylesbury, United Kingdom |
Study Chair: | Merav Bassan, PhD. | Teva Pharmaceuticals Industries LTD |
Responsible Party: | Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations ) |
Study ID Numbers: | ALS-GA-201 |
Study First Received: | May 16, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00326625 |
Health Authority: | United States: Food and Drug Administration; France: Ministry of Health |
Copolymer 1 Amyotrophic lateral sclerosis Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Lou Gehrig's disease Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease Motor Neuron Disease |
Pathologic Processes Immunologic Factors Physiological Effects of Drugs Nervous System Diseases |
Adjuvants, Immunologic Immunosuppressive Agents Pharmacologic Actions |